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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 4681–4700 of 39,430 recalls

Class IIOngoing

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR,

GE Medical Systems, LLC

Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

October 28, 2024 · DeviceView details →
Class IIIOngoing

Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode

Remote Diagnostic Technologies Ltd.

Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.

October 28, 2024 · DeviceView details →
Class IIOngoing

Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)

Noah Medical

Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or equal to 1100mm) will pass through if scope channel positioned in sharp bend (approx. greater than 100-deg.), excessive force may result in tissue injury/pneumothorax; instruments with long rigid distal sections may exhibit insertion resistance when bronchoscope bending section significantly articulated.

October 25, 2024 · DeviceView details →
Class IIOngoing

Galaxy System (GAL-001)

Noah Medical

Bronchoscopic system uninterruptable power may have defective component, may cause power supply short circuit/trip protective circuit breakers causing sudden, unrecoverable power loss, which could occur while system is on mains or internal battery power; if during procedure, could cause interrupted/aborted procedure, may necessitate manual removal, which could lead to lung injury/pneumothorax.

October 25, 2024 · DeviceView details →
Class IIOngoing

ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555

MEDLINE INDUSTRIES, LP - Northfield

Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or zipper bag label. Medline is recalling its kits which utilize affected product as a component.

October 25, 2024 · DeviceView details →
Class IIOngoing

GE Proteus XR/A radiographic system

GE Healthcare (China) Co., Ltd.

Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List.

October 24, 2024 · DeviceView details →
Class IIOngoing

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis

Baxter Healthcare Corporation

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

October 23, 2024 · DeviceView details →
Class IIOngoing

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis

Baxter Healthcare Corporation

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

October 23, 2024 · DeviceView details →
Class IIOngoing

Lab Kit, SKU DYLAB1018; Component No. 503581

MEDLINE INDUSTRIES, LP - Northfield

Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.

October 23, 2024 · DeviceView details →
Class IIOngoing

URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581

MEDLINE INDUSTRIES, LP - Northfield

Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.

October 23, 2024 · DeviceView details →
Class IIOngoing

Clean Catch Kit, SKU DYKM1833A; Component No. 503581

MEDLINE INDUSTRIES, LP - Northfield

Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.

October 23, 2024 · DeviceView details →
Class IIOngoing

MICRO-X Rover Mobile X-ray System, # MXU-RV19

Micro-X Ltd.

During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the prep/expose switch, the prep switch can be activated for a very short time such that the orange ring of death is displayed in the tube cooling area of the screen. The system then becomes unresponsive to kV/mAs changes, prep/expose presses. The only way to proceed is to suspend the patient, Exit Nexus DR and relogin and continue the exam.

October 23, 2024 · DeviceView details →
Class IIOngoing

Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number T5C4326K; use in Peritoneal Dialysis

Baxter Healthcare Corporation

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

October 23, 2024 · DeviceView details →
Class IIOngoing

UA KIT, SKU DYKM1690A; Component No. 503581

MEDLINE INDUSTRIES, LP - Northfield

Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.

October 23, 2024 · DeviceView details →
Class IIOngoing

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis

Baxter Healthcare Corporation

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

October 23, 2024 · DeviceView details →
Class IIOngoing

URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004A DYLAB1006 DYLAB1012 ; Component No. 503581

MEDLINE INDUSTRIES, LP - Northfield

Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.

October 23, 2024 · DeviceView details →
Class IIOngoing

Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K; use in Peritoneal Dialysis

Baxter Healthcare Corporation

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

October 23, 2024 · DeviceView details →
Class IIOngoing

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis

Baxter Healthcare Corporation

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

October 23, 2024 · DeviceView details →
Class IIOngoing

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis

Baxter Healthcare Corporation

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

October 23, 2024 · DeviceView details →
Class IIOngoing

URINE KIT, SKU DYKM1845; Component No. 503581

MEDLINE INDUSTRIES, LP - Northfield

Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.

October 23, 2024 · DeviceView details →
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